An observational study in Eye Diseases, sponsored by Aesculap AG. Completed at 1 site in Malaysia. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Aesculap AG · Observational
This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample size can be given but the planned sample size shall be at least 200 eyes (around 100 patients depending on the number of operated eyes per patient) to conduct meaningful subgroup analysis.
740 studies on the registry are indexed under Eye Diseases; 118 are open to participants now.
This study's enrollment of 200 is above the median of 120 across 172 observational studies indexed under Eye Diseases.
Browse Eye Diseases studies →Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who underwent any ophthalmic surgery using Dafilon® suture in the participating centre between 2018 and 2020.
Exclusion Criteria:
any ophthalmic surgery using Dafilon® suture
Number of Suture material complications
Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence)
Time frame: up to the retrospective examination (2 to 4 years postoperatively)
Number of Intra-operative complications
Number of Intra-operative complications as documented in the patient's record
Time frame: intraoperatively
Number of Post-operative complications
Cumulative number of Post-operative complications including Haemorrhage, inflammation and tissue reaction, corneal lesion, retraction, granuloma, and contracture at the postoperative follow-up examination
Time frame: up to the retrospective examination (2 to 4 years postoperatively)
Incidence of recurrence
Cumulative number of recurrencies
Time frame: up to the retrospective examination (2 to 4 years postoperatively)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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